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Risk Evaluation and Mitigation Strategy (REMS) Pharmacy Enrollment Form — Independent Pharmacy Because of the teratogenic risk associated with therapy, is available through a limited program under
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What is under form rems only?
Under Form REMS only refers to information that is reported to the FDA under the Risk Evaluation and Mitigation Strategy (REMS) program.
Who is required to file under form rems only?
Manufacturers of certain prescription drugs that are subject to REMS requirements are required to file under Form REMS only.
How to fill out under form rems only?
Form REMS only can be filled out electronically through the FDA's Electronic Submissions Gateway (ESG).
What is the purpose of under form rems only?
The purpose of filing under Form REMS only is to provide the FDA with important safety information regarding prescription drugs subject to REMS requirements.
What information must be reported on under form rems only?
Information such as adverse events, medication errors, and laboratory test results related to the REMS program must be reported on Form REMS only.
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